EP1276439B1 - Prothese individuelle de valvule du sinus veineux - Google Patents

Prothese individuelle de valvule du sinus veineux Download PDF

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Publication number
EP1276439B1
EP1276439B1 EP01945061A EP01945061A EP1276439B1 EP 1276439 B1 EP1276439 B1 EP 1276439B1 EP 01945061 A EP01945061 A EP 01945061A EP 01945061 A EP01945061 A EP 01945061A EP 1276439 B1 EP1276439 B1 EP 1276439B1
Authority
EP
European Patent Office
Prior art keywords
venous valve
valve prosthesis
matrix
venous
recipient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP01945061A
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German (de)
English (en)
Other versions
EP1276439A1 (fr
Inventor
Gbr Corlife
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Corlife OHG
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Corlife OHG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Corlife OHG filed Critical Corlife OHG
Publication of EP1276439A1 publication Critical patent/EP1276439A1/fr
Application granted granted Critical
Publication of EP1276439B1 publication Critical patent/EP1276439B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2475—Venous valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415—Manufacturing methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3633—Extracellular matrix [ECM]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/062—Apparatus for the production of blood vessels made from natural tissue or with layers of living cells

Definitions

  • the invention relates to the use of a recipient-specific transformed synthetic matrix for the preparation of an individual venous valve prosthesis.
  • Venous disease occupies an essential place among the civilization diseases. Every year, many people suffer from venous insufficiency, mainly in the so-called industrial countries. Lack of exercise also contributes to the increasing prevalence of this disease, such as dietary errors and obesity. Chronic venous insufficiency is a problem of considerable public health concern, as a significant proportion of the adult population is affected and prolonged hospitalization, in some cases inability to work, may be the ultimate consequence. The risk of pulmonary embolism as a result of thrombosis also poses a considerable risk. Conservative treatment makes chronic venous insufficiency scarcely possible and is treated with support stockings and dressings. In the advanced state, the venous valves are completely destroyed, i.
  • the disadvantage of the various surgical reconstruction methods is that the flap can not be restored completely to the original state, so that there remains a risk of further deterioration, in particular, ulcus cruris.
  • Elaborate reconstruction methods therefore entail the disadvantage of longer operating times and the associated risks.
  • Another disadvantage is that the venous valve immediately after surgery must be fully loaded again, so the operation area can be spared in any way. Surgery injuries, scars or even small clots on the venous valve lead to a relatively high risk of thrombosis, which immediately puts into question the success of these surgical procedures.
  • WO 98/49972 discloses a device for treating various parts of a prosthetic product containing vascular tissue, e.g. B. may include a heart valve.
  • the vascular tissue may be acellularized tissue.
  • US 5,863,296 discloses bioprosthetic xenografts, such as heart valve implants, whose endogenous cells are killed before further treatment.
  • WO 00/64569 discloses the production of a venous valve prosthesis (see page 5, lines 23-26 in connection with page 16, lines 38-40) from an acellularized matrix (page 17, lines 24-28), colonizing the acellularized matrix with autologous cells
  • WO 01/28459 discloses comparable features as the WO 00/64569 in which a venous valve frame of a synthetic, biodegradable material is provided as the matrix.
  • the prosthesis includes a tubular fluid channel having a stent with the valve flaps attached to the inner surface of the stent.
  • the object of the invention is therefore to open up new possibilities for combating venous insufficiency.
  • the invention provides the use of a recipient-specific transformed acellularized matrix for the production of an individual venous valve prosthesis.
  • the present invention provides a method of making an individual venous valve prosthesis according to claim 1.
  • a major advantage of the invention is that the finished, "healthy" venous valve prosthesis can be used in a total of a shorter operation step and thereby replaces the defective flap.
  • the connections are on smooth cuts that are relatively uncomplicated to connect and lead away from a risk of thrombosis in the flap itself.
  • a "recipient-specific transformation” is preferably understood to mean a colonization of the selected matrix with recipient-compatible cells, in particular with autologous cells of the prosthesis recipient.
  • the matrix described in more detail below is colonized so far with recipient-compatible cells that the thrombogenicity of the foreign body "venous valve prosthesis" is sufficiently suppressed. Also, the type of settled cells has an impact on thrombogenicity.
  • Particularly suitable is a colonization with fibroblasts and endothelial cells as well as possibly with myofibroblasts.
  • the matrix used for the recipient-specific transformation is a synthetic matrix, for example of a biopolymeric material, a polymeric material common to prostheses, and more particularly a biodegradable polymeric material.
  • a suitable material would be e.g. a lactide-containing polymer, preferably a copolymer of lactide and a glycol compound, more preferably multi-layered polydioxanone.
  • the matrix may also be a xenogeneic or allogeneic matrix for the recipient from which substantially all natural cells have been removed from or from the surface thereof prior to the recipient-specific transformation.
  • the base matrix used for the recipient-specific transformation may be a natural venous valve.
  • the acellularization of such xenogeneic or allogeneic venous valves can be done in a manner known per se, for example by enzymatic detachment of the cells, e.g. with trypsin, or by peeling, and / or killing the cells with chemical and / or mechanical means.
  • a recipient-specific transformed matrix material is used for the construction of a venous valve prosthesis.
  • the venous valve prosthesis is composed of several matrix components.
  • the selected materials are pre-colonized prior to the construction of the venous valve prosthesis and may optionally be coated after construction in a further process step with a non-thrombogenic material on the surface or additionally colonized with recipient-specific cells.
  • the venous valve prosthesis preferably comprises at least one valve leaflet.
  • the venous valve prosthesis comprises a vein piece of a certain overall length, wherein it is provided that the venous valve is located in a vein piece whose length above and below the flap area in each case at least once the diameter of the vein or corresponds to the flap cross-section.
  • a major advantage of the invention is that the venous valve processed in the manner indicated and, if necessary, specially newly designed for the recipient, can be prepared in possibly several travel steps in such a way that the danger of thrombosis for the associated selected recipient remains as low as possible.
  • the function of the venous valve prosthesis can be tested at least in vitro by the venous valve is clamped in a corresponding device and pulsed with a culture medium or even simple (crystalloid) solution perfused.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Manufacturing & Machinery (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Claims (3)

  1. Procédé pour fabriquer une prothèse individuelle de valve veineuse, avec les étapes qui consistent :
    à préparer une matrice synthétique,
    à implanter dans la matrice des cellules autologues du receveur de prothèse,
    à fabriquer la prothèse de valve veineuse en utilisant la matrice avec lesdites cellules implantées, de telle sorte que la prothèse de valve veineuse comprenne une partie de veine d'une longueur égale à au moins une fois le diamètre de la section transversale de la valvule au-dessus et au-dessous de celle-ci, étant précisé qu'avec la prothèse de valve veineuse fabriquée, aucune valvule n'est fixée à la surface intérieure d'un stent.
  2. Procédé selon la revendication 1, la matrice synthétique étant préparée à partir d'un biopolymère, d'un polymère ou d'un polymère biodégradable.
  3. Procédé selon la revendication 1 ou 2, la prothèse de valve veineuse comprenant au moins une valvule.
EP01945061A 2000-04-27 2001-04-27 Prothese individuelle de valvule du sinus veineux Expired - Lifetime EP1276439B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10020540 2000-04-27
DE10020540 2000-04-27
PCT/EP2001/004796 WO2001080782A1 (fr) 2000-04-27 2001-04-27 Prothese individuelle de valvule du sinus veineux

Publications (2)

Publication Number Publication Date
EP1276439A1 EP1276439A1 (fr) 2003-01-22
EP1276439B1 true EP1276439B1 (fr) 2010-03-24

Family

ID=7640045

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01945061A Expired - Lifetime EP1276439B1 (fr) 2000-04-27 2001-04-27 Prothese individuelle de valvule du sinus veineux

Country Status (7)

Country Link
US (1) US20040024447A1 (fr)
EP (1) EP1276439B1 (fr)
AT (1) ATE461678T1 (fr)
AU (1) AU6738801A (fr)
CA (1) CA2407439C (fr)
DE (1) DE50115407D1 (fr)
WO (1) WO2001080782A1 (fr)

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US10856984B2 (en) 2017-08-25 2020-12-08 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US10940001B2 (en) 2012-05-30 2021-03-09 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US11311376B2 (en) 2019-06-20 2022-04-26 Neovase Tiara Inc. Low profile prosthetic mitral valve
US11357622B2 (en) 2016-01-29 2022-06-14 Neovase Tiara Inc. Prosthetic valve for avoiding obstruction of outflow
US11389291B2 (en) 2013-04-04 2022-07-19 Neovase Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
US11413139B2 (en) 2011-11-23 2022-08-16 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11419720B2 (en) 2010-05-05 2022-08-23 Neovasc Tiara Inc. Transcatheter mitral valve prosthesis
US11464631B2 (en) 2016-11-21 2022-10-11 Neovasc Tiara Inc. Methods and systems for rapid retraction of a transcatheter heart valve delivery system
US11491006B2 (en) 2019-04-10 2022-11-08 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
US11497602B2 (en) 2012-02-14 2022-11-15 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US11602429B2 (en) 2019-04-01 2023-03-14 Neovasc Tiara Inc. Controllably deployable prosthetic valve
US11737872B2 (en) 2018-11-08 2023-08-29 Neovasc Tiara Inc. Ventricular deployment of a transcatheter mitral valve prosthesis
US11779742B2 (en) 2019-05-20 2023-10-10 Neovasc Tiara Inc. Introducer with hemostasis mechanism
US11998447B2 (en) 2020-03-06 2024-06-04 Neovasc Tiara Inc. Retrievable prosthesis delivery system

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EP2967945B1 (fr) 2013-03-15 2020-10-28 California Institute of Technology Mécanisme de poignée et fonctionnalité permettant de repositionner et d'extraire des valvules cardiaques transcathéter
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US11419720B2 (en) 2010-05-05 2022-08-23 Neovasc Tiara Inc. Transcatheter mitral valve prosthesis
US11413139B2 (en) 2011-11-23 2022-08-16 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11497602B2 (en) 2012-02-14 2022-11-15 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US11617650B2 (en) 2012-05-30 2023-04-04 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US11389294B2 (en) 2012-05-30 2022-07-19 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US10940001B2 (en) 2012-05-30 2021-03-09 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US11389291B2 (en) 2013-04-04 2022-07-19 Neovase Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
US11357622B2 (en) 2016-01-29 2022-06-14 Neovase Tiara Inc. Prosthetic valve for avoiding obstruction of outflow
US11464631B2 (en) 2016-11-21 2022-10-11 Neovasc Tiara Inc. Methods and systems for rapid retraction of a transcatheter heart valve delivery system
US10856984B2 (en) 2017-08-25 2020-12-08 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11793640B2 (en) 2017-08-25 2023-10-24 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11737872B2 (en) 2018-11-08 2023-08-29 Neovasc Tiara Inc. Ventricular deployment of a transcatheter mitral valve prosthesis
US11602429B2 (en) 2019-04-01 2023-03-14 Neovasc Tiara Inc. Controllably deployable prosthetic valve
US11491006B2 (en) 2019-04-10 2022-11-08 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
US11779742B2 (en) 2019-05-20 2023-10-10 Neovasc Tiara Inc. Introducer with hemostasis mechanism
US11311376B2 (en) 2019-06-20 2022-04-26 Neovase Tiara Inc. Low profile prosthetic mitral valve
US11931254B2 (en) 2019-06-20 2024-03-19 Neovasc Tiara Inc. Low profile prosthetic mitral valve
US11998447B2 (en) 2020-03-06 2024-06-04 Neovasc Tiara Inc. Retrievable prosthesis delivery system

Also Published As

Publication number Publication date
WO2001080782A1 (fr) 2001-11-01
AU6738801A (en) 2001-11-07
CA2407439A1 (fr) 2002-10-25
EP1276439A1 (fr) 2003-01-22
CA2407439C (fr) 2008-07-08
US20040024447A1 (en) 2004-02-05
DE50115407D1 (de) 2010-05-06
ATE461678T1 (de) 2010-04-15

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